Guided bone regeneration at dehiscence comparing synthetic bone substitute versus bovine bone mineral: A multicenter, noninferiority, randomized trial.

Jae-Kook Cha, Ui-Won Jung, Eduardo Montero-Solis, Ignacio Sanz-Sánchez, Mariano Sanz-Alonso
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Abstract

Aim: To evaluate the efficacy of guided bone regeneration (GBR) for the treatment of peri-implant dehiscence defects using a synthetic bone substitute (SBS) or a deproteinized bovine bone mineral (DBBM) as a bone substitute.

Methods: Patients with expected dehiscence defects following implant placement were randomized to use either SBS or DBBM together with a bioabsorbable collagen membrane over dehiscenced implant surfaces aimed for GBR. The changes in the bone defect size were measured before the GBR procedure and 6 months after implant placement at the re-entry surgery. Secondary outcomes included peri-implant health outcomes, implant cumulative survival rates, bone level changes, and patient-reported outcomes (PROMs) at prosthesis delivery and 1-year follow-up.

Results: Of the 49 included patients, 24 were treated with SBS and 25 with DBBM. In the SBS group, the defect height (DH) at implant insertion was 5.1 ± 2.6 mm and was reduced at re-entry to 1.3 ± 2.0 mm (74.5%). In the DBBM group, the respective changes in DH were 4.1 ± 1.7 mm and 1.5 ± 1.9 mm (63.4%). These differences were not statistically significant (p = 0.216). The complete defect resolution rate was also comparable in both groups without statistical difference (62.5% of patients (15/24) vs. 44% of patients (11/25)). Overall, the marginal bone levels remained stable during the 1-year follow-up in both groups.

Conclusion: The SBS is noninferior to DBBM for simultaneous GBR to implant placement at implant sites with buccal dehiscences in terms of defect resolution and evaluated secondary outcomes (KCT0008393 - this clinical trial was not registered before participant recruitment and randomization).

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人工合成骨替代物与牛骨矿物质在开裂处引导骨再生的比较:多中心、非劣效随机试验。
目的:使用合成骨替代物(SBS)或脱蛋白牛骨矿物质(DBBM)作为骨替代物,评估引导骨再生(GBR)治疗种植体周围开裂缺损的疗效:方法:对植入种植体后出现预期开裂缺损的患者进行随机分组,在开裂的种植体表面使用SBS或DBBM以及生物可吸收胶原膜进行GBR治疗。在 GBR 术前和种植体植入 6 个月后的再入路手术中测量骨缺损大小的变化。次要结果包括种植体周围健康结果、种植体累积存活率、骨水平变化以及假体交付和一年随访时患者报告的结果(PROMs):在 49 名患者中,24 人接受了 SBS 治疗,25 人接受了 DBBM 治疗。在 SBS 组中,植入假体时的缺损高度(DH)为 5.1 ± 2.6 毫米,再次植入时降至 1.3 ± 2.0 毫米(74.5%)。DBBM 组的 DH 变化分别为 4.1 ± 1.7 毫米和 1.5 ± 1.9 毫米(63.4%)。这些差异没有统计学意义(P = 0.216)。两组患者的完全缺损修复率也相当,无统计学差异(62.5% 的患者(15/24)对 44% 的患者(11/25))。总体而言,两组患者的边缘骨水平在1年的随访期间均保持稳定:结论:在有颊部开裂的种植部位同时进行 GBR 和种植体植入时,SBS 在缺陷解决和次要结果评估方面均不优于 DBBM(KCT0008393 - 该临床试验在参与者招募和随机化之前未注册)。
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